MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
|
Back to Search Results |
|
Model Number 97715 |
Device Problem
Overheating of Device (1437)
|
Patient Problems
Unspecified Infection (1930); Seroma (2069); Burning Sensation (2146)
|
Event Date 08/08/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a manufacturing representative (rep) and a patient.It was reported that for about the past week, the patient has noticed a burning sensation at their pocket site when they are done recharging, only at the end.The patient mentioned that if they sit too long or lay on their implantable neurostimulator (ins) site, they have the same sensation.The rep stated that the patient was examined by the healthcare provider (hcp), and it was noted that the patient had fluid accumulation at the ins site.The hcp ordered antibiotics and a ct scan.The rep indicated that the hcp will follow-up with the patient on (b)(6) 2020, and they won¿t have any further information until then.
|
|
Manufacturer Narrative
|
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Manufacturer representative responded back from follow up sent.Pain and fluid continues.Hcp said no infection and no plans to address further.
|
|
Search Alerts/Recalls
|
|
|